MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW LOCKING TOWER ENH 2019; SPINE SURGICAL INSTRUMENT

Catalog Number	03.51.10.0583
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2024 lot 2256325: (b)(4) items manufactured and released on (b)(6) 2023.No anomalies found related to the problem.To date, other 3 similar events have been reported on the same lot during the period of review (in the same complaint) additional instruments involved batch review performed on (b)(6) 2024 on pedicle screw 03.51.10.0583 locking tower enh 2019 lot.2157553 lot 2157553: 8 items manufactured and released on (b)(6) 2022.No anomalies found related to the problem.To date, another similar event has been reported on the same lot during the period of review (in the same complaint).Batch review performed on 20 march 2024 on pedicle screw 03.51.10.0583 locking tower enh 2019 lot.1955445 lot 1955445: (b)(4) items manufactured and released on (b)(6) 2020.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Batch review performed on 20 march 2024 on pedicle screw 03.51.10.0583 locking tower enh 2019 lot.2154100 lot 2154100: (b)(4) items manufactured and released on (b)(6) 2021.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.
Event or Problem Description
The platine part of 8 different locking tower enh 2019 was broken during surgery.Delay time 1 hour and a half (total time 4 hours).Surgery completed successfully anyway.
Additional Manufacturer Narrative
Visual inspection performed by medacta spine r&d project manager: one piece of lot 2256325 is conform and doesn't present any sign of damage.All other pieces have a broken platine and/or broken flap.This may have been caused by not optimal alignment between the instrument and the pedicle screw head, during reduction operation: if this happens, the retaining pins don't enter the respective socket in the head, leading to excessive load on the welding.Modifications have been introduced to weldings indications and inspection method to improve the manufacturing process and potentially reduce failure events.E1 added country.It is (b)(6).

• Brand Name: PEDICLE SCREW LOCKING TOWER ENH 2019
• Common Device Name: SPINE SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19086099
• Report Number: 3005180920-2024-00216
• Device Sequence Number: 7699224
• Product Code: LXH
• UDI-Device Identifier: 07630971256538
• UDI-Public: 07630971256538
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.51.10.0583
• Device Lot Number: 2256325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female